ConMed Infinity ACL Tibial Elbow Guide Recalled for Misalignment
ConMed Corporation is recalling 73 units of the Infinity ACL Tibial Elbow Guide because the tips may be misaligned, potentially affecting the accuracy of the guide system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (inaccurate surgical guidance) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
ConMed Corporation is recalling 73 units of the Infinity ACL Tibial Elbow Guide (Catalog Number: KTE100). This medical device is indicated for use in open and arthroscopic procedures for knee ligament reconstruction.
The recall was initiated because the tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally. This misalignment could affect the accuracy of the guide system. The affected units are identified by the following lot codes: 201926AB, 201942AF, 201947AF, 202007AF, 202011 AF, 202015AF, and 202024AF.
The 73 units were distributed nationwide in the United States (23 units) and in foreign countries including Canada, Thailand, Taiwan, and South Africa (50 units). The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these devices.
The recalled product
- Product
- Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
- Manufacturer
- ConMed Corporation
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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